Trial Outcomes & Findings for Field Usability Study of Eclipse Mask (NCT NCT05559047)
NCT ID: NCT05559047
Last Updated: 2025-11-10
Results Overview
The total count of participants who asked for additional information during the course of home use of the mask was recorded
COMPLETED
70 participants
Throughout the duration of the study (48 hours)
2025-11-10
Participant Flow
In this study, seventy adherent CPAP users volunteered to trial the Eclipse mask for two nights in their homes. Participants attended an appointment at one of three offices of Sleep Centers of Middle Tennessee (SCMT) and were trained how to use the Eclipse mask, then asked to use the Eclipse for two consecutive nights and then complete a participant survey after the second night. No control group was used. Volunteers were gathered from the pool of SCMT participants.
Participant milestones
| Measure |
Eclipse Mask Group (Single Arm Study)
A single group was used, namely those trying the Eclipse mask at home for 2 nights
|
|---|---|
|
Overall Study
STARTED
|
70
|
|
Overall Study
COMPLETED
|
70
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Field Usability Study of Eclipse Mask
Baseline characteristics by cohort
| Measure |
Eclipse Mask (Single Arm Study)
n=70 Participants
Seventy adherent CPAP users will volunteer to trial the Eclipse mask for two nights in their homes. Participants who attend an appointment at one of three offices of Sleep Centers of Middle Tennessee (SCMT) and will be trained on how to use the Eclipse mask, then asked to use the Eclipse for two consecutive nights and then complete a participant survey after the second night.
Eclipse novel CPAP mask: Participants will follow instructions to set up and put on the Eclipse nasal mask. The Eclipse removes the headgear associated with traditional CPAP masks, offering a small compact design weighing less than an ounce. The Eclipse uses small and lightweight adhesive seals around the nostrils to create an ergonomic design which accommodates the shape of each individual user. It completes a perfect circuit for CPAP therapy to deliver pressure to the airway and stabilize the user's disordered breathing during sleep (apnea and snoring).
Participants will follow instructions to set up and put on the mask. They will fill out a survey about the ease and comfort of putting on and wearing the mask, briefly.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
68 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
2 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
26 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
44 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
23 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black
|
26 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
14 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
7 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Throughout the duration of the study (48 hours)The total count of participants who asked for additional information during the course of home use of the mask was recorded
Outcome measures
| Measure |
Eclipse Novel CPAP Mask
n=70 Participants
Participants will follow instructions to set up and put on the Eclipse nasal mask. The Eclipse removes the headgear associated with traditional CPAP masks, offering a small compact design weighing less than an ounce. The Eclipse uses small and lightweight adhesive seals around the nostrils to create an ergonomic design which accommodates the shape of each individual user. It completes a perfect circuit for CPAP therapy to deliver pressure to the airway and stabilize the user's disordered breathing during sleep (apnea and snoring).
|
|---|---|
|
Number of Participants Who Asked for Additional Information
|
6 Participants
|
PRIMARY outcome
Timeframe: At 48 hoursA 16-item patient survey was administered to the participants at the end of the study. Patients had to answer according to a Likert scale (1: worst, 5:best). Here, this reflects the average of all the answered items. For example, question number one had an average score of 4.52, question number 2 had an average score of 4.21, etc. Since all questions reflect mask likability, they were averaged to provide an overall score.
Outcome measures
| Measure |
Eclipse Novel CPAP Mask
n=70 Participants
Participants will follow instructions to set up and put on the Eclipse nasal mask. The Eclipse removes the headgear associated with traditional CPAP masks, offering a small compact design weighing less than an ounce. The Eclipse uses small and lightweight adhesive seals around the nostrils to create an ergonomic design which accommodates the shape of each individual user. It completes a perfect circuit for CPAP therapy to deliver pressure to the airway and stabilize the user's disordered breathing during sleep (apnea and snoring).
|
|---|---|
|
Mask Likeability
|
4.1 score
Standard Deviation 0.4
|
PRIMARY outcome
Timeframe: The duration of the trial (48 h)Total count of participants who reported technical issues during the course of the 48 h home use of the mask were recorded
Outcome measures
| Measure |
Eclipse Novel CPAP Mask
n=70 Participants
Participants will follow instructions to set up and put on the Eclipse nasal mask. The Eclipse removes the headgear associated with traditional CPAP masks, offering a small compact design weighing less than an ounce. The Eclipse uses small and lightweight adhesive seals around the nostrils to create an ergonomic design which accommodates the shape of each individual user. It completes a perfect circuit for CPAP therapy to deliver pressure to the airway and stabilize the user's disordered breathing during sleep (apnea and snoring).
|
|---|---|
|
Number of Participants Who Experienced Technical Issues
|
7 Participants
|
Adverse Events
Eclipse Novel CPAP Mask
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place